Emergency LaparotomyNCT04615520
Evaluation of Surgical Risk Prediction Tools.
An observational study of Emergency Laparotomy, run by University Hospital of Crete at 1 site in Greece.
Trial summary
Introduction: In modern surgery, the prediction of perioperative death gains significant importance due to the availability of treatment options, means of improving the surgical outcome and for proper patient information. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency Laparotomy
- How many people
- 660 participants
- Where
- 1 siteGreece
- Study dates
- 1 May 2020to 1 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted in a surgical department during a 12-month study period (May 1, 2020 - May 1, 2021 ).
Who may be able to join
- Age >18yrs
- Emergency laparotomy (operation simultaneously with resuscitation usually within one hour) or urgent (operation as soon as possible after resuscitation, within 24hrs)
- Operation in the gastrointestinal tract:
- Open or laparoscopic, or laparoscopically assisted procedures.
- Procedures involving the stomach, small or large bowel, or rectum for conditions such as perforation, ischaemia, abdominal abscess, bleeding or obstruction
- Wash out/evacuation of intraperitoneal abscess or haematoma
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- Bowel resection/repair due to incarcerated/incisional hernias
- Bowel resection or repair due to incarcerated umbilical, inguinal or femoral hernias
- Open or laparoscopic adhesiolysis
- Laparotomy/laparoscopy with inoperable pathology
- Return to theatre for repair of a substantial dehiscence of major abdominal wound (i.e. "burst abdomen")
- Return to theatre after any operation (including vascular, gynecology, urology, cardiac) meeting the criteria above
- In the case of multiple procedures in the abdominopelvic cavity the patient is included if the main procedure is a general surgical one (i.e. if bowel resection happens during an open aneurysm repair it should not be included)
- Any intra-abdominal procedure not identifiable within exclusion criteria should be included.
Who cannot join
- Patients under 18
- Elective operation
- Diagnostic laparoscopy or laparotomy where no other procedure is performed (NB, if no procedure is performed due to inoperable pathology, then include)
- Appendicectomy with or without drainage of localized abscess
- Cholecystectomy with or without drainage of localized abscess
- Hernia repair without bowel resection
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- Minor abdominal wound revision
- Vascular surgery
- Gynecological surgery - c-section - ruptured ectopic pregnancy
- Surgery relating to organ transplantation
- Removal of dialysis catheters
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Surgery, University Hospital of Heraklion
Heraklion, 71110
About this study
Official title: A Multicenter Comparison of Risk Prediction Tools for Emergency Laparotomy in Greece
Introduction: In modern surgery, the prediction of perioperative death gains significant importance due to the availability of treatment options, means of improving the surgical outcome and for proper patient information. However, patient heterogeneity and the existence of multiple risk prediction tools complicate the prediction of perioperative mortality. Thus, prognostic tools are developed based on the analysis of preoperative variables. Most commonly used models are POSSUM, ACS-NSQIP, NELA and POTTER. The models have been assessed in West-European and North-American populations, each with different prognostic value.
Aim: Comparative analysis of predictive accuracy of the aforementioned risk prediction tools in Greek population.
Read more
Materials and Methods: The study is multicenter, non-interventional, prospective and observational and includes patients undergoing emergency laparotomies of general surgery. In cases of multiple operations in one hospitalization, the first operation is included. The clinical-laboratory variables, derived from POSSUM, NELA, ACS-NSQIP and POTTER models are recorded anonymously in a secure online database, REDCap (Research Electronic Data Capture).The minimum estimated number of included patients in order to accomplish statistically significant results is 600. Each of the centers submitted in the study, is expected to include approximately 60 patients in a period of 6-12 months. For the statistical analysis of data, Brier Score will be used and ROC with statistical significance lower than 0.05.
Conclusions: Upon completion of this study, the most accurate perioperative risk prediction tool in the Greek population is expected to be proposed.
- Conditions
- Emergency Laparotomy
- Keywords
- emergency laparotomy, risk prediction, postoperative mortality, NELA, ACS-risk calculator, POSSUM
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of deaths within 30 days from emergency laparotomy
Patients who died of any cause within 30 days from emergency laparotomy
Measured: 30 days after emergency laparotomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start1 May 2020
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emergency LaparotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 660 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Crete
- Sponsor type
- University, hospital or other
- Collaborators
- Nicosia General Hospital, Laikο General Hospital, Athens, Attikon Hospital, Evangelismos Hospital, Trikala General Hospital, Trikala, Ippokrateio General Hospital of Thessaloniki, General Hospital of Volos, University General Hospital of Patras, University Hospital, Ioannina
- Responsible party
- Principal investigator, Konstantinos Lasithiotakis, University Hospital of Crete
- Investigators
- Konstantinos Lasithiotakis, Principal investigator, University Hospital of Heraklion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615520
- Sponsor's protocol ID
- 1681/26-02-2020
- Status last verified
- Dec 2021
- First submitted
- 28 Oct 2020
- Last updated
- 28 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No there is no plan to make IPD available to other researchers.
Publications
Kokkinakis S, Kritsotakis EI, Paterakis K, Karali GA, Malikides V, Kyprianou A, Papalexandraki M, Anastasiadis CS, Zoras O, Drakos N, Kehagias I, Kehagias D, Gouvas N, Kokkinos G, Pozotou I, Papatheodorou P, Frantzeskou K, Schizas D, Syllaios A, Palios IM, Nastos K, Perdikaris M, Michalopoulos NV, Margaris I, Lolis E, Dimopoulou G, Panagiotou D, Nikolaou V, Glantzounis GK, Pappas-Gogos G, Tepelenis K, Zacharioudakis G, Tsaramanidis S, Patsarikas I, Stylianidis G, Giannos G, Karanikas M, Kofina K, Markou M, Chrysos E, Lasithiotakis K. Prospective multicenter external validation of postoperative mortality prediction tools in patients undergoing emergency laparotomy. J Trauma Acute Care Surg. 2023 Jun 1;94(6):847-856. doi: 10.1097/TA.0000000000003904. Epub 2023 Feb 2.
PubMed 36726191
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Comparison of Risk Prediction Tools for Emergency Laparotomy in Greece
- ClinicalTrials.gov ID
- NCT04615520
- Acronym / sponsor ID
- 1681/26-02-2020
- Conditions
- Emergency Laparotomy
- Keywords
- emergency laparotomy, risk prediction, postoperative mortality, NELA, ACS-risk calculator, POSSUM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 660 participants (actual)
- Lead sponsor
- University Hospital of CreteUniversity, hospital or other
- Collaborators
- Nicosia General Hospital, Laikο General Hospital, Athens, Attikon Hospital, Evangelismos Hospital, Trikala General Hospital, Trikala, Ippokrateio General Hospital of Thessaloniki, General Hospital of Volos, University General Hospital of Patras, University Hospital, Ioannina
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: In modern surgery, the prediction of perioperative death gains significant importance due to the availability of treatment options, means of improving the surgical outcome and for proper patient information. However, patient heterogeneity and the existence of multiple risk prediction tools complicate the prediction of perioperative mortality. Thus, prognostic tools are developed based on the analysis of preoperative variables. Most commonly used models are POSSUM, ACS-NSQIP, NELA and POTTER. The models have been assessed in West-European and North-American populations, each with different prognostic value.
Aim: Comparative analysis of predictive accuracy of the aforementioned risk prediction tools in Greek population.
Materials and Methods: The study is multicenter, non-interventional, prospective and observational and includes patients undergoing emergency laparotomies of general surgery. In cases of multiple operations in one hospitalization, the first operation is included. The clinical-laboratory variables, derived from POSSUM, NELA, ACS-NSQIP and POTTER models are recorded anonymously in a secure online database, REDCap (Research Electronic Data Capture).The minimum estimated number of included patients in order to accomplish statistically significant results is 600. Each of the centers submitted in the study, is expected to include approximately 60 patients in a period of 6-12 months. For the statistical analysis of data, Brier Score will be used and ROC with statistical significance lower than 0.05.
Conclusions: Upon completion of this study, the most accurate perioperative risk prediction tool in the Greek population is expected to be proposed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted in a surgical department during a 12-month study period (May 1, 2020 - May 1, 2021 ).
Key inclusion criteria (14 listed)
- Age >18yrs
- Emergency laparotomy (operation simultaneously with resuscitation usually within one hour) or urgent (operation as soon as possible after resuscitation, within 24hrs)
- Operation in the gastrointestinal tract:
- Open or laparoscopic, or laparoscopically assisted procedures.
- Procedures involving the stomach, small or large bowel, or rectum for conditions such as perforation, ischaemia, abdominal abscess, bleeding or obstruction
Key exclusion criteria (11 listed)
- Patients under 18
- Elective operation
- Diagnostic laparoscopy or laparotomy where no other procedure is performed (NB, if no procedure is performed due to inoperable pathology, then include)
- Appendicectomy with or without drainage of localized abscess
- Cholecystectomy with or without drainage of localized abscess
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of deaths within 30 days from emergency laparotomy
Time frame: 30 days after emergency laparotomy
Patients who died of any cause within 30 days from emergency laparotomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- Derived from this study: PubMed 36726191Kokkinakis S, Kritsotakis EI, Paterakis K, Karali GA, Malikides V, Kyprianou A, Papalexandraki M, Anastasiadis CS, Zoras O, Drakos N, Kehagias I, Kehagias D, Gouvas N, Kokkinos G, Pozotou I, Papatheodorou P, Frantzeskou K, Schizas D, Syllaios A, Palios IM, Nastos K, Perdikaris M, Michalopoulos NV, Margaris I, Lolis E, Dimopoulou G, Panagiotou D, Nikolaou V, Glantzounis GK, Pappas-Gogos G, Tepelenis K, Zacharioudakis G, Tsaramanidis S, Patsarikas I, Stylianidis G, Giannos G, Karanikas M, Kofina K, Markou M, Chrysos E, Lasithiotakis K. Prospective multicenter external validation of postoperative mortality prediction tools in patients undergoing emergency laparotomy. J Trauma Acute Care Surg. 2023 Jun 1;94(6):847-856. doi: 10.1097/TA.0000000000003904. Epub 2023 Feb 2.
- Individual participant dataSharing planned: No. No there is no plan to make IPD available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konstantinos Lasithiotakis principal investigator
University Hospital of Heraklion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergency Laparotomy, run by University Hospital of Crete at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of deaths within 30 days from emergency laparotomy (time frame: 30 days after emergency laparotomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04615520, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2021; AzTrials last refreshed its copy on 6 Nov 2026.